21.B.433 Findings and corrective actions; observations

SI No. 588/2023

(a) The CAA must have a system in place to analyse findings for their safety significance.

(b) The CAA must issue a level 1 finding where a severe non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139, with the organisation’s procedures or manuals, or with the design organisation’s certificate including the terms of approval, which may lead to uncontrolled non-compliances and to a potential unsafe condition.

(c) Level 1 findings include:

1. any failure to grant the CAA access to the organisation’s facilities referred to in point 21.A.8 during normal operating hours and after two written requests;

2. obtaining the design organisation approval or maintaining its validity by falsification of the submitted documentary evidence:

3. any evidence of malpractice or fraudulent use of the design organisation approval;

4. failure to appoint a head of the design organisation pursuant to point 21.A.245(a).

(d) The CAA must issue a level 2 finding where any non-compliance, which is not classified as a level 1 finding is detected with the applicable requirements of Regulation (EU) 2018/1139, with the organisation’s procedures or manuals, or with the certificate including the terms of approval.

(e) Where a finding is detected during oversight or by any other means, the CAA must, without prejudice to any additional action required by Regulation (EU) 2018/1139, communicate in writing the finding to the organisation and request corrective action to address the non-compliance identified.

1. where there are any level 1 findings:

(i) the CAA must grant the organisation a corrective action implementation period, appropriate to the nature of the finding, which must not be more than 1 month commencing from the date of the written communication of the finding to the organisation under point (e);

(ii) the CAA must assess the corrective action plan and implementation plan proposed by the organisation, and if it concludes that they are sufficient to address the non-compliance, accept them;

(iii) where the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted by the CAA, take immediate and appropriate action to prohibit or limit the activities of the organisation involved and, if appropriate, take action to revoke the design organisation approval or to limit or suspend it in whole or in part, depending on the extent of the level 1 finding, until successful corrective action has been taken by the organisation.

2. Where there are any level 2 findings:

(i) the CAA must grant the organisation a corrective action implementation period, appropriate to the nature of the finding, which must not be more than 3 months commencing from the date of the written communication of the finding to the organisation under point (e). At the end of the 3 month period, and subject to the nature of the finding, the CAA may extend the 3 month period provided that a corrective action plan has been agreed by the CAA;

(ii) the CAA must assess the corrective action and the implementation plan proposed by the organisation, and if it concludes that they are sufficient to address the non-compliance, accept them;

(iii) where the organisation fails to submit an acceptable corrective action plan or fails to perform the corrective action within the time period accepted or extended by the CAA, the CAA must raise the finding to level 1 and action must be taken as laid down in point (d)(1).

(f) The CAA may issue observations for any of the following cases not requiring level 1 or level 2 findings:

1. for any item whose performance has been assessed as ineffective;

2. when it has been identified that an item has the potential to cause a non-compliance under points (b), (c) or (d);

3. when suggestions or improvements are of interest for the overall safety performance of the organisation.

(g) The observations issued under this point must be communicated in writing to the organisation and recorded by the CAA.